|Publication number||US7618567 B2|
|Application number||US 10/978,321|
|Publication date||17 Nov 2009|
|Filing date||29 Oct 2004|
|Priority date||1 May 1998|
|Also published as||CA2371841A1, EP1191884A1, US6183497, US20020038133, US20050059080, US20100029908, US20130172737, WO2000078228A1, WO2000078228A9|
|Publication number||10978321, 978321, US 7618567 B2, US 7618567B2, US-B2-7618567, US7618567 B2, US7618567B2|
|Inventors||Eduardo Chi Sing, Mark Ashby|
|Original Assignee||Boston Scientific Scimed, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (99), Non-Patent Citations (45), Classifications (24), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a divisional of U.S. application Ser. No. 09/966,611 filed Sep. 27, 2001, now abandoned, which is a continuation of U.S. application Ser. No. 09/630,814, filed Aug. 2, 2000, now abandoned, which is a divisional of U.S. application Ser. No. 09/335,452, filed Jun. 17, 1999, now U.S. Pat. No. 6,183,497, which is a continuation in part of U.S. application Ser. No. 09/071,670, filed May 1, 1998, now U.S. Pat. No. 6,071,301 and U.S. application Ser. No. 09/071,284, filed May 1, 1998, now U.S. Pat. No. 6,162,192.
1. Field of the Invention
The invention relates to an absorbable sponge, and more particularly, the invention relates to the delivery of a contrasting agent to a specific area or site in a mammal after a surgical or interventional procedure. The contrasting agent facilitates the location of the area or site even weeks or months after the initial procedure.
2. Brief Description of the Related Art
Percutaneous needle biopsy of solid organs is one of the most common interventional medical procedures. Millions of percutaneous needle biopsies are performed annually in the United States and throughout the world. Percutaneous biopsy is a safe procedure which has supplanted surgical biopsy for many indications, such as biopsy and liver biopsy.
Possible complications of needle biopsy include bleeding at the biopsy site. The amount of bleeding is related to a number of factors including needle size, tissue sample size, patient's coagulation status, and the location of the biopsy site. Vascular organs such as the liver, a common biopsy target, may bleed significantly after needle biopsy.
Sterile sponges, such as GELFOAM, are prepared in dry sterile sheets which are used as packing material during surgery for control of bleeding. The sponge sheets are left in the surgical site after surgery to stop bleeding and are absorbed by the body. A number of techniques have used these absorbable sterile sponge materials to plug a biopsy tract to minimize or prevent bleeding. The absorbable sponge provides a mechanical blockage of the tract, encourages clotting, and minimizes bleeding though the biopsy tract.
During the biopsy, a mechanic clip device is often attached to the site where tissue is removed, so that if further treatment is later required the location of the site can be identified. Unfortunately, the time period between the biopsy and treatment may be weeks during which time the clip may become dislodged thereby making it difficult to relocate the site.
Accordingly, it would be desirable to provide a reliable technique for identifying biopsy sites or puncture wound sites.
The present invention is based in part on the discovery that adding a contrasting agent (e.g, radiopaque agent) to an absorbable sponge provides for a material that not only facilitates hemostasis of a biopsy tract or other puncture wound but also permits precise identification of the site's location.
Accordingly, in one aspect, the invention is directed to a method for marking a bodily site in a patient that includes the steps of:
identifying the bodily site; and
positioning a pledget of absorbable sponge material adjacent the bodily site wherein the absorbable sponge material includes a contrasting agent.
With the present invention, the exact location of the bodily site can be located many weeks or longer following positioning of the absorbable sponge material.
In another aspect, the invention is directed to a method for performing a biopsy that included the steps of:
removing tissue from a vascular tissue site; and
positioning a pledget of absorbable sponge material adjacent the vascular tissue site wherein the absorbable sponge material includes a contrasting agent.
In another aspect, the invention is directed to a liquid permeable, absorbable, gelatin sponge that is prepared by a process that includes the steps of:
(a) preparing an aqueous gelatin solution;
(b) adding an organic solvent in the aqueous gelatin solution to form a second solution;
(c) incubating the second solution;
(d) forming a foam from the second solution wherein a contrasting agent is added to the second solution at any step prior to forming the foam; and
(e) drying the foam.
The invention will now be described in greater detail with reference to the preferred embodiments illustrated in the accompanying drawings, in which like elements bear like reference numerals, and wherein:
The present invention is directed to an absorbable sponge material containing a contrasting agent. The absorbable sponge material is delivered to a specific area or site in a patient (i.e., mammal) after a surgical or interventional procedure. For example, the sponge material can be placed in the biopsy tract or other puncture wound and the contrasting agent enables marking or identification of the area or site. The absorbable sponge will be described in connection with treatment of a biopsy tract after a percutaneous needle biopsy. The absorbable sponge material can also exhibit secondary benefits of, for example, facilitating hemostasis and delivering therapeutic agents.
Prior to discussing the present invention in further detail, the following terms are defined:
“Pledget” means a piece of absorbable sponge containing a contrasting agent preferably of a generally elongated shape having a size which allows injection in a hydrated state through a biopsy needle or other cannula.
“Sponge” means a biocompatible material which is capable of being hydrated and is resiliently compressible in a hydrated state. Preferably, the sponge is non-immunogenic and is absorbable.
“Absorbable sponge” means a sponge which when implanted within a patient (i.e., human or other mammalian body) is absorbed by the body. The absorbable sponge contains a contrasting agent which may or may not be absorbable. Besides the contrasting agent, the sponge can also be used to deliver a beneficial agent such as thrombin, radiation treatment or the like.
“Bodily site” means any tissue in a mammal where the absorbable sponge containing the contrasting agent can be introduced. The invention is particularly suited for introducing the absorbable sponge into tissue sites where further treatment may be required, for example, as in the case following biopsy.
“Hydrate” means to partially or fully saturate with a fluid, such as, saline, water, or the like.
“Kneading” of the absorbable sponge material means both dry and wet manipulation of the sponge material which compresses, enlarges, or changes the shape of the sponge material causing the sponge material to have improved expansion response.
“Contrasting agent” means a biocompatible material that is capable of being detected or monitored by fluoroscopy, X-ray photography, CAT scan, ultrasound, or similar imaging techniques following placement into a mammalian subject. Preferred contrasting agents are radiopaque materials. The contrast agent can be either water soluble or water insoluble. Examples of water soluble contrast agents include metrizamide, iopamidol, iothalamate sodium, iodomide sodium, and meglumine. Examples of water insoluble contrast agents include tantalum, tantalum oxide, and barium sulfate, each of which is commercially available. Other water insoluble contrast agents include gold, tungsten, and platinum powders. Some radiopaque contrasting agents are available in liquid form. These include, for example, OMNIPAQUE from Nycomed, Inc., Princeton, N.J. Preferably, the contrast agent is water insoluble (i.e., has a water solubility of less than 0.01 mg/ml at 20° C.).
The absorbable sponge material of the present invention is preferably a liquid permeable, water insoluble gelatin based sponge that has contrasting agent incorporated in the matrix of the sponge. By “incorporated” is meant that the contrasting agent is substantially dispersed throughout the sponge so that the contrasting material is not simply found on the periphery of the sponge. The sponge is made by mixing a suitable organic solvent (e.g., formaldehyde) with an aqueous solution of gelatin. The organic solvent facilitates the cross linkage of gelatin polymers. It is expected that glutaraldehyde may also be suitable. The resulting solution is then incubated typically at slightly above room temperature (30°-40° C.). Subsequently, a contrasting agent is added and the resulting mixture beaten to produce a firm foam. Thereafter, the foam is dried to produce the absorbable sponge material.
Typically, the aqueous gelatin solution containing 3-10% gelatin by weight is prepared as a warm solution (e.g., 80° C.) to help dissolve the gelatin. The solution is then allowed to cool (e.g, 35°-40° C.) before the organic solvent is added. A preferred organic solvent is formalin (an aqueous solution of formaldehyde). The amount of formalin used will control the hardness of the sponge and its rate of absorption into the body. The more formalin used, the harder the sponge and the lower the absorption rate. Typically, the amount used is between 0.01 to 10% based on the gelatin solution. The beating or whipping process takes about 5-15 or more minutes to produce a firm foam of about 4 to 8 times the volume of the original solution. The drying process initially begins with oven drying in the presence of circulating air at about 30° to 33° C. or higher and 10% humidity. After the foam is thoroughly dried, the foam can be heated to an elevated temperature of about 140° C. for a sufficient length of time (e.g., 3 hrs) until the sponge is firm. Suitable absorbable sponge materials are further described in U.S. Pat. No. 2,465,357 which is incorporated herein by reference.
It has been found that at least for contrasting agents that are not soluble in water, the contrasting agent must be added prior to beating the gelatin/formalin solution. The reason is that once the foam material is produced, the contrasting agent cannot be incorporated into the matrix of the sponge.
When employing contrasting agents that are liquids it is preferred that they be added to the gelatin/formalin solution prior to being beaten to form the foam product. This will insure that the contrasting agent is dispersed throughout the sponge.
Care should be taken when using insoluble contrasting agents not to overload the absorbable sponge material by using excessive amounts of contrasting agents. This will possibly result in sponges that have reduced cell structures, that is, the final volume will be significantly less than if no contrasting agent was used.
Following the above formulation, absorbable sponge materials containing different amounts of contrasting agent were prepared and tested. Specifically, 5 grams of pork gelatin (Bloom value 275) were mixed in 100 grams of water at 80° C. and the solution was allowed to cool to 35° C. before 0.03 cc of 40% formalin was added. The resulting solution was incubated at 35° C. for 2 hours before tantalum powder (50 to 150 grams) was added. The liquid was then vigorously mixed in a malt mixer to produce a foam. The foam was then oven dried at 35° C. for 12 hours.
The absorbable sponge material was examined with a fluoroscope and found to be extremely visible. Moreover, placement of the sponge material with contrasting agent in puncture sites of a swine model demonstrated that the absorbable sponge exhibited good hemostatic properties as well.
The sponge material with contrasting agent of the present invention is particularly suited for biopsies and other percutaneous procedures where knowledge of the site of initial treatment, e.g., tissue removal, is important.
While the absorbable sponge material can be employed with any suitable medical instrument, a preferred device and method for facilitating hemostasis of a biopsy tract is described herein to illustrate use of the absorbable sponge material. This technique is further described in U.S. patent application Ser. No. 09/247,880, filed on Feb. 10, 1999, and entitled “Device and Method for Facilitating Hemostasis of a Biopsy Tract,” now U.S. Pat. No. 6,086,607, is incorporated herein by reference.
The adaptor 12 which delivers the hydrated pledget 18 to the needle 16 includes a first end 30 having an annular lip 32 or female luer fitting for connection to the syringe 14. A second end 34 of the adaptor 12 has a male luer fitting 36 for connection to a biopsy needle 16 or other cannula. The luer fitting 36 includes a tapered external surface 38 and a retaining ring 40 with internal threads for receiving an annular lip of the biopsy needle. The adaptor 12 has an internal lumen with a first diameter D1 at the first end 30 and a second diameter D2 at the second end 34. Between the first and second ends of the adaptor 12 a tapered section 42 of the adaptor provides a funnel for compressing the hydrated pledget 18 prior to injection through the biopsy needle 16 and needle hub 28.
The adaptor 12 may be formed in any known manner such as by molding from a plastic material. Preferably, the adaptor 12 is transparent so that the pledget 18 can be viewed through the adaptor and the user can visually monitor when the pledget is loaded within the adaptor and when the pledget has been delivered into the needle. The adaptor lumen may be provided with a friction reducing coating for improved delivery. The delivery fluid also reduces friction for improved delivery by wetting the exterior surface of the pledget 18.
As shown in
The biopsy needle 16 used with the present invention is preferably a co-axial biopsy needle, such as a bi-axial or a tri-axial biopsy needle. A co-axial biopsy needle includes an outer needle or cannula through which a tissue sample is removed with a tissue scoop or other biopsy instrument. Once the tissue sample has been removed, the outer cannula remains in the patient as illustrated in
A preferred method of facilitating hemostasis of a biopsy tract will be described with reference to
After the biopsy procedure has been completed, the outer sheath of the biopsy needle 16 through which the biopsy has been taken is maintained in place within the biopsy tract, as shown in
The absorbable sponge material of the present invention can be shaped into the required size by conventional means. Pledgets may be cut with a punch or a stencil or template and knife. Once hydrated, the pledget 18 can be easily compressed to fit into a lumen having a smaller cross sectional area than the original cross sectional area of the pledget. Additionally, the kneading of the hydrated pledget 18 during delivery encourages air trapped within the absorbable sponge to be expelled and replaced with fluid, allowing rapid expansion upon delivery.
When delivering a pledget 118 of absorbable sponge material, it is important to deliver a desired amount of the sponge material using a minimum amount of fluid.
Pledgets 118 with increased cross sectional area proximal ends may be prepared in a variety of manners. For example, if a pledget 118 is prepared from a sheet of sponge material, the increased proximal mass can be achieved by cutting the pledget with an enlarged proximal end. Alternatively, the pledget 118 may be formed by folding, rolling, compressing, or otherwise manipulating the sponge material to the desired shape. The proximal pledget mass may also be increased by adding separate pieces of material to the proximal end of the pledget. This additional material may be layered, wrapped, coiled or attached to the pledget in any other manner. The pledgets may also be formed by molding, bump extruding, dipping, or the like. The larger cross sectional area proximal end is generally about 1.2 to 4 times the cross sectional area of the distal end. In addition, the proximal end with the larger cross section area preferably extends along about ⅛ to ¾ of the total pledget length.
The pledget 118 illustrated in
As described above, the pledget may be delivered to the biopsy tract by holding the biopsy needle or cannula 16 stationary and injecting the pledget through the biopsy needle. If additional pledgets are to be delivered, the biopsy needle 16 is withdrawn a distance sufficient to accommodate an additional pledget and the additional pledget is then injected.
An alternative method of delivering the pledget into the biopsy tract includes withdrawing the biopsy needle or cannula 16 during delivery of the pledget 18 to deliver the pledget in an elongated trail which follows the biopsy tract. Placing the absorbable sponge material in a trail which fills the entire biopsy tract provides the added benefit of providing hemostasis along the entire biopsy tract. This is particularly helpful for stopping the bleeding of biopsy tracts in organs which tend to have excessive bleeding such as the liver, kidney, spleen, and other vascular organs.
In order to achieve a trail of absorbable sponge material in the biopsy tract, one method of the present invention involves the delivery of the pledget into the biopsy needle by a predetermined amount of fluid. The biopsy needle is then withdrawn at a velocity V while the pledget material is ejected from the biopsy needle at a velocity E with respect to the biopsy needle. The velocity V at which the biopsy needle is withdrawn is equal to or less than the velocity E at which the absorbable sponge material is delivered. The control of injection of fluid and withdrawal of the needle to achieve the desired trail of absorbable sponge material in the biopsy tract maybe controlled with an injection controlling device.
According to an alternative embodiment as illustrated in
As an alternative to delivery of the pledget as a trail, the pledget may be delivered as a plug. To deliver a plug the plunger 80 is advanced into the needle 16 pushing the pledget out of the distal end of the needle while the needle is held stationary. A combination of delivery of plugs and trails may also be used. The pledget material may be delivered entirely within a single anatomical structure or may cross two or more anatomical structures such as an organ, surrounding tissue and facial layer.
In some instances it may be desirable to deliver multiple pledgets in spaced apart positions along the biopsy tract, particularly for a long biopsy tract. For delivery of additional pledgets, the biopsy needle 16 is retracted a distance sufficient to provide a space to accommodate an additional pledget 18 and the injection procedure described above is repeated for the additional pledget(s). For a particularly large biopsy site or cavity, additional pledgets 18 may be injected beside an initially injected pledget until the cavity is filled.
Although biopsy is most commonly performed by biopsy needle, biopsy may also be performed through other cannulas, such as catheters, long needles, endoscopes, or the like. The treatment procedure according to the present invention can be used for facilitating hemostasis of puncture wounds through different types of cannulas including needles, catheters, endoscopes, and the like. In addition, the treatment procedure and systems according to the present invention may be used to deliver absorbable or non-absorbable sponge for other therapys. For example, sponge may be delivered for cosmetic or reconstructive bulking or for temporary or permanent intravascular embolization.
In addition to the contrasting agent, the absorbable sponge pledget 18 may be used to deliver a beneficial agent, such as, thrombin, radiation treatment, or the like. The pledget can also be used to deliver therapeutic agents, such as radioactive isotopes for localized treatment of tumors, anti-cancer agents, anti-metastatic agents, and the like. Examples of anti-cancer agents include 5-fluorouracil, cisplatin, prednisone, and others described in U.S. Pat. No. 4,619,913 which is incorporated herein by reference. The absorbable sponge pledget 18 may be presoaked with the beneficial agent for delivery to the biopsy tract. Alternatively, the pledget 18 may be hydrated with the beneficial liquid agent or the agent may be delivered to the pledget after the pledget is placed within the biopsy tract.
A pledget formed of inventive absorbable sponge material preferably will be absorbed by the body within 1 to 6 weeks. However, the pledget material may be designed to provide different rates of absorption. If the contrasting agent employed is also absorbable, the contrasting agent should be absorbed at approximately the same rate as the sponge material. Where the contrasting agent is non-absorbable, it will remain at the site.
While the invention has been described in detail with reference to the preferred embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed, without departing from the present invention.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US581235||24 Feb 1897||20 Apr 1897||Island|
|US1578517||23 Dec 1924||30 Mar 1926||George N Hein||Valve piston and barrel construction for hypodermic syringes|
|US2086580||24 Jun 1935||13 Jul 1937||Shirley Myron C||Applicator|
|US2370319||7 Nov 1944||27 Feb 1945||Dohner & Lippincott||Paper perforator|
|US2465357||14 Aug 1944||29 Mar 1949||Upjohn Co||Therapeutic sponge and method of making|
|US2492458||8 Dec 1944||27 Dec 1949||Jr Edgar A Bering||Fibrin foam|
|US2507244||14 Apr 1947||9 May 1950||Upjohn Co||Surgical gelatin dusting powder and process for preparing same|
|US2558395||26 Mar 1948||26 Jun 1951||Hoffmann La Roche||Undenatured gelatin hemostatic sponge containing thrombin|
|US2597011||28 Jul 1950||20 May 1952||Us Agriculture||Preparation of starch sponge|
|US2680442||4 Apr 1952||8 Jun 1954||Linzmayer Frank L||Disposable suppository casing|
|US2761446||30 Mar 1955||4 Sep 1956||Chemical Specialties Co Inc||Implanter and cartridge|
|US2814294||17 Apr 1953||26 Nov 1957||Becton Dickinson Co||Unit for and method of inhibiting and controlling bleeding tendencies|
|US2824092||4 Jan 1955||18 Feb 1958||Thompson Robert E||Process of preparation of a gelatincarboxymethyl cellulose complex|
|US2874776||31 Dec 1956||24 Feb 1959||Royal Mcbee Corp||Punch and die mechanism|
|US2899362||11 Aug 1959||Hemostatic sponges and method of|
|US2997195||18 May 1960||22 Aug 1961||Chuen Yuen Yat||Drinking straws|
|US3157524||13 Mar 1962||17 Nov 1964||Ethicon Inc||Preparation of collagen sponge|
|US3358689||9 Jun 1964||19 Dec 1967||Roehr Products Company Inc||Integral lancet and package|
|US3411505||15 Dec 1965||19 Nov 1968||Paul D. Nobis||Device for interrupting arterial flow|
|US3703174||14 Jul 1970||21 Nov 1972||Medidyne Corp||Method and apparatus for catheter injection|
|US3724465||22 Jul 1971||3 Apr 1973||Kimberly Clark Co||Tampon coated with insertion aid and method for coating|
|US3736939||7 Jan 1972||5 Jun 1973||Kendall & Co||Balloon catheter with soluble tip|
|US4000741||3 Nov 1975||4 Jan 1977||The Kendall Company||Syringe assembly|
|US4098728||2 Jan 1976||4 Jul 1978||Solomon Rosenblatt||Medical surgical sponge and method of making same|
|US4211323||1 Dec 1978||8 Jul 1980||California Medical Developments, Inc.||Disposable diagnostic swab having a stored culture medium|
|US4218155||10 Feb 1978||19 Aug 1980||Etablissements Armor, S.A.||Stick for applying a liquid|
|US4219026||15 Sep 1978||26 Aug 1980||The Kendall Company||Bladder hemostatic catheter|
|US4224945||30 Aug 1978||30 Sep 1980||Jonathan Cohen||Inflatable expansible surgical pressure dressing|
|US4238480||19 May 1978||9 Dec 1980||Sawyer Philip Nicholas||Method for preparing an improved hemostatic agent and method of employing the same|
|US4292972||9 Jul 1980||6 Oct 1981||E. R. Squibb & Sons, Inc.||Lyophilized hydrocolloio foam|
|US4323072||8 May 1980||6 Apr 1982||Shiley, Incorporated||Cannula for a vein distention system|
|US4340066||1 Feb 1980||20 Jul 1982||Sherwood Medical Industries Inc.||Medical device for collecting a body sample|
|US4390018||17 May 1982||28 Jun 1983||Zukowski Henry J||Method for preventing loss of spinal fluid after spinal tap|
|US4404970||22 Jul 1980||20 Sep 1983||Sawyer Philip Nicholas||Hemostatic article and methods for preparing and employing the same|
|US4405314||19 Apr 1982||20 Sep 1983||Cook Incorporated||Apparatus and method for catheterization permitting use of a smaller gage needle|
|US4515637||16 Nov 1983||7 May 1985||Seton Company||Collagen-thrombin compositions|
|US4573576||27 Oct 1983||4 Mar 1986||Krol Thomas C||Percutaneous gastrostomy kit|
|US4587969||28 Jan 1985||13 May 1986||Rolando Gillis||Support assembly for a blood vessel or like organ|
|US4588395||28 Oct 1980||13 May 1986||Lemelson Jerome H||Catheter and method|
|US4591094||13 Aug 1984||27 May 1986||Arthur Morris||Fountain|
|US4619261||9 Aug 1984||28 Oct 1986||Frederico Guerriero||Hydrostatic pressure device for bleeding control through an inflatable, stitchable and retrievable balloon-net system|
|US4619913||21 May 1985||28 Oct 1986||Matrix Pharmaceuticals, Inc.||Treatments employing drug-containing matrices for introduction into cellular lesion areas|
|US4644649||26 Sep 1985||24 Feb 1987||Seaman Roy C||Apparatus for trimming reeds of musical instruments|
|US4645488||30 Nov 1983||24 Feb 1987||Board Of Trustees Of The University Of Alabama||Syringe for extrusion of wetted, particulate material|
|US4699616||13 Jun 1986||13 Oct 1987||Hollister Incorporated||Catheter retention device and method|
|US4708718||2 Jul 1985||24 Nov 1987||Target Therapeutics||Hyperthermic treatment of tumors|
|US4744364||17 Feb 1987||17 May 1988||Intravascular Surgical Instruments, Inc.||Device for sealing percutaneous puncture in a vessel|
|US4790819||24 Aug 1987||13 Dec 1988||American Cyanamid Company||Fibrin clot delivery device and method|
|US4829994||27 May 1987||16 May 1989||Kurth Paul A||Femoral compression device for post-catheterization hemostasis|
|US4832688||7 Apr 1987||23 May 1989||Terumo Kabushiki Kaisha||Catheter for repair of blood vessel|
|US4836204||6 Jul 1987||6 Jun 1989||Landymore Roderick W||Method for effecting closure of a perforation in the septum of the heart|
|US4839204||12 May 1987||13 Jun 1989||Yazaki Kakoh Co., Ltd.||Resin coated metal pipe having a plane surface for a lightweight structure|
|US4850960||8 Jul 1987||25 Jul 1989||Joseph Grayzel||Diagonally tapered, bevelled tip introducing catheter and sheath and method for insertion|
|US4852568||28 Dec 1987||1 Aug 1989||Kensey Nash Corporation||Method and apparatus for sealing an opening in tissue of a living being|
|US4869143||27 Jul 1988||26 Sep 1989||Merrick Industries, Inc.||Card file punch|
|US4890612||16 May 1988||2 Jan 1990||Kensey Nash Corporation||Device for sealing percutaneous puncture in a vessel|
|US4900303||25 Mar 1986||13 Feb 1990||Lemelson Jerome H||Dispensing catheter and method|
|US4929246||27 Oct 1988||29 May 1990||C. R. Bard, Inc.||Method for closing and sealing an artery after removing a catheter|
|US4936835||23 Dec 1988||26 Jun 1990||Haaga John R||Medical needle with bioabsorbable tip|
|US4950234||25 May 1988||21 Aug 1990||Sumitomo Pharmaceuticals Company, Limited||Device for administering solid preparations|
|US5007895||5 Apr 1989||16 Apr 1991||Burnett George S||Wound packing instrument|
|US5021059||7 May 1990||4 Jun 1991||Kensey Nash Corporation||Plug device with pulley for sealing punctures in tissue and methods of use|
|US5049138||13 Nov 1989||17 Sep 1991||Boston Scientific Corporation||Catheter with dissolvable tip|
|US5053046||6 Sep 1990||1 Oct 1991||Woodrow W. Janese||Dural sealing needle and method of use|
|US5061274||4 Dec 1989||29 Oct 1991||Kensey Nash Corporation||Plug device for sealing openings and method of use|
|US5080655||26 Apr 1990||14 Jan 1992||Haaga John R||Medical biopsy needle|
|US5106376||3 Jul 1990||21 Apr 1992||B. Braun Melsungen Ag||Anaesthesia set|
|US5108421||1 Oct 1990||28 Apr 1992||Quinton Instrument Company||Insertion assembly and method of inserting a vessel plug into the body of a patient|
|US5129889||25 Jun 1990||14 Jul 1992||Hahn John L||Synthetic absorbable epidural catheter|
|US5160323||24 May 1990||3 Nov 1992||Andrew Daniel E||Method and system for inserting spinal catheters|
|US5163904||12 Nov 1991||17 Nov 1992||Merit Medical Systems, Inc.||Syringe apparatus with attached pressure gauge|
|US5167624||9 Nov 1990||1 Dec 1992||Catheter Research, Inc.||Embolus delivery system and method|
|US5192290||29 Aug 1990||9 Mar 1993||Applied Medical Resources, Inc.||Embolectomy catheter|
|US5192300||28 Jan 1992||9 Mar 1993||Quinton Instrument Company||Insertion assembly and method of inserting a vessel plug into the body of a patient|
|US5192301||3 Sep 1991||9 Mar 1993||Nippon Zeon Co., Ltd.||Closing plug of a defect for medical use and a closing plug device utilizing it|
|US5195988||4 Nov 1991||23 Mar 1993||Haaga John R||Medical needle with removable sheath|
|US5219899||19 Oct 1992||15 Jun 1993||Degussa Aktiengesellschaft||Pasty dental material which is an organopolysilane filler combined with a polymerizable bonding agent|
|US5220926||13 Jul 1992||22 Jun 1993||Jones George T||Finger mounted core biopsy guide|
|US5221259||5 Dec 1991||22 Jun 1993||Novoste Corporation||Wound treating device and method of using same|
|US5232453||17 Jun 1992||3 Aug 1993||E. R. Squibb & Sons, Inc.||Catheter holder|
|US5242683||19 Jul 1990||7 Sep 1993||Nycomed Imaging As||Contrast media comprising a paramagnetic agent and an iodinated agent for x-ray and mri|
|US5254105||10 Jun 1992||19 Oct 1993||Haaga John R||Sheath for wound closure caused by a medical tubular device|
|US5275616||18 Dec 1992||4 Jan 1994||Quinton Instrument Company||Insertion assembly and method of inserting a vessel plug into the body of a patient|
|US5282827||5 Mar 1992||1 Feb 1994||Kensey Nash Corporation||Hemostatic puncture closure system and method of use|
|US5299581||30 Jun 1992||5 Apr 1994||Donnell John T||Intravaginal device|
|US5310407||30 Oct 1992||10 May 1994||Datascope Investment Corp.||Laparoscopic hemostat delivery system and method for using said system|
|US5320639||12 Mar 1993||14 Jun 1994||Meadox Medicals, Inc.||Vascular plug delivery system|
|US5322515||15 Mar 1993||21 Jun 1994||Abbott Laboratories||Luer adapter assembly for emergency syringe|
|US5325857||9 Jul 1993||5 Jul 1994||Hossein Nabai||Skin biopsy device and method|
|US5334216||10 Dec 1992||2 Aug 1994||Howmedica Inc.||Hemostatic plug|
|US5342388||25 Mar 1993||30 Aug 1994||Sonia Toller||Method and apparatus for sealing luminal tissue|
|US5350399||7 Oct 1992||27 Sep 1994||Jay Erlebacher||Percutaneous arterial puncture seal device and insertion tool therefore|
|US5352211||11 Jul 1993||4 Oct 1994||Louisville Laboratories||External stability device|
|US5366480||15 Dec 1992||22 Nov 1994||American Cyanamid Company||Synthetic elastomeric buttressing pledget|
|US5370656||26 Feb 1993||6 Dec 1994||Merocel Corporation||Throat pack|
|US5383896||25 May 1993||24 Jan 1995||Gershony; Gary||Vascular sealing device|
|US5383899||23 Feb 1994||24 Jan 1995||Hammerslag; Julius G.||Method of using a surface opening adhesive sealer|
|US5385550||29 Mar 1994||31 Jan 1995||Su; Chan-Ho||Needle protective means for prevention against stab and virus infection|
|US5388588||4 May 1993||14 Feb 1995||Nabai; Hossein||Biopsy wound closure device and method|
|1||"Gelfoam Sterile Powder," Pharmacia & Upjohn Manufacturer Brochure, Feb. 1996.|
|2||"Gelfoam Sterile Powder," Pharmacia & Upjohn Manufacturer Brochure, Mar. 1996.|
|3||"Gelfoam Sterile Sponge, Sterile Powder and Sterile Film," Pharmacia & Upjohn Manufacturer Brochure, May 1997, p. 1.|
|4||"Gelfoam Sterile Sponge, Sterile Powder and Sterile Film," Pharmacia & Upjohn Manufacturer Specification, Nov. 1996, p. 1.|
|5||(130) Ashby, Mark et al; U.S. Appl. No. 10/069,107, filed Dec. 16, 2002; entitled: Device And Method For Determining A Depth Of An Incision.|
|6||(144) Ashby, Mark et al; U.S. Appl. No. 10/278,710, filed Oct. 22, 2002; entitled: "System and Method for Facilitating Hemostasis of Blood Vessel Punctures With Absorbable Sponge".|
|7||(152) Ashby, Mark et al; U.S. Appl. No. 10/334,770, filed Dec 31, 2002; entitled: "Improved System and Method for Facilitating Hemostasis with Absorbable Sponge".|
|8||(154) Ashby, Mark et al; U.S. Appl. No. 10/421,680, filed Apr. 22, 2003; entitled: "Puncture Closure System With Pin and Pull Technique".|
|9||(159) Ashby, Mark et al; U.S. Appl. No. 10/462,065, filed Jun. 12, 2003; entitled: "Enhanced Bleed Back System".|
|10||(160) Ashby, Mark et al, U.S. Appl. No. 10/462,064, filed Jun. 12, 2003; entitled: "Release Mechanism".|
|11||(161) Ashby, Mark et al; U.S. Appl. No. 10/461,587, filed Jun. 12, 2003; entitled: "Dissolvable Closure Device".|
|12||(162) Ashby, Mark et al; U.S. Appl. No. 10/461,035, filed Jun. 13,2003; entitled: "System And Method For Delivering Hemostasis Promoting Material to A Blood Vessel Puncture Site Using a Cannula".|
|13||(163) Ashby, Mark et al; U.S. Appl. No. 10/461,006, filed Jun. 13, 2003; entitled: "System and Method for Delivering Hemostasis Promoting Material to a Blood Vessel Puncture with a Staging Tube".|
|14||(164) Ashby, Mark et al; U.S. Appl. No. 10/460,859, filed Jun. 12, 2003; entitled: "Hemostatic Device Including a Capsule".|
|15||(187) Ashby, Mark et al; U.S. Appl. No. 10/732,441, filed Dec. 9, 2003; entitled: "Pledget-Handling System and Method for Delivering Hemostasis Promoting Material to a Blood Vessel Puncture Site by Fluid Pressure".|
|16||(190) Ashby, Mark et al; U.S. Appl. No. 10/754,824, filed Jan. 9,2004; entitled: "Sheath-Mounted Arterial Plug Delivery Device".|
|17||Allison, D., "Percutaneous Liver Biopsy and Track Embolization with Steel Coils," Radiology, vol. 169, 1998, p. 261.|
|18||Berman, Howard L., "Guided Direct Antegrade Puncture of the Superficial Femoral Artry," American Ray Society Roentgen, Sep. 1986, p. 632.|
|19||Berman, Howard L., "Modification of the Cope Drainage Catheter to Facilitate Placement," American Ray Society Roentgen, Jan. 1986, pp. 146, 169.|
|20||Bryne, J., "Endovascular Treatments for Intracranial Anuerysms," The British Journal of Radiology, 1996, pp. 98, 891.|
|21||Chuang, V., "Sheath Needle for Liver Biopsy in High-Risk Patience," Radiology, vol. 166, 1988, p. 261.|
|22||Correll, John T., "Biologic Investigations of New Absorbable Sponge," Research Laboratories of the Upjohn Company, 1945, p. 585.|
|23||Correll, John T., "Certain Properties of a New Physiologically Absorbable Sponge, " Research Laboratories of the Upjohn Company, 1944, p. 233.|
|24||Di Seni, Ricardo, "Part 1, Embolotherapy: Agents, Equipment, and Techniques," Vascular Embolotherapy, vol. 4, p. 29.|
|25||Fandrich, C., "Small Guage Gelfoam Plug Liver Biopsy in High Risk Patients," Australian Radiology, vol. 40, 1996, p. 230. High Risk Patients, Australian Radiology, vol. 40, 1996, p. 230.|
|26||Foran, JPM, "Early Mobilization After Percutaneous Cardiac Catheterisation Using Collagen Plug (Vasoseal) Maemostatis," BRHeart, vol. 69, 1993, p. 424.|
|27||Gibbs, JSR, "Femoral Arterial Hemostasis Using a Collagen Plug After Coronary Artery Stent Implantation," J. Interventional Card, vol. 5, 1992, p. 85.|
|28||Journal of Interventional Cardiology, vol. 5, No. 2, Jun. 1992.|
|29||Kassell, "Size of Intracanial Aneurysm," vol. 12, No. 3, 1983.|
|30||Kiemeneiji, F., "Improved Anticoagulation Management after Palmaz Schatz Coronary Stent Implantation by Sealing the Arterial Puncture Site with Vascular Hemostasis Device," Catheterization and Cardiovascular Diagnosis, vol. 30, 1995, p. 1685.|
|31||Kussmaul, WG, "Rapid Arterial Hemostasis . . . Randomized Trial of a Novel Hemostatic Device," J. Am. Coll. Card., vol. 25, 1995, p. 1685.|
|32||Our Pending Applications (125) Ashby, Mark et al; U.S. Appl. No. 10/287,922, filed Nov. 4, 2002; entitled: Apparatus And Method For Inhibiting Blood Loss.|
|33||Riley, SA, "Percutaneous Liver Biopsy with Plugging of Needle Track: a Safe Method for Use in Patients with Impaired Coagulation," The Lancet, 1964, p. 436.|
|34||Saddekni, S., M.D., "Antegrade Cathererization of the Superficial Femoral Artery," Radiology, 1985, p. 531.|
|35||Sanborn, T., "Multicenter Randomized Trial Comparing Perutaneous Collagen Hemostasis Device with Conventional Manual Compression after Diagnostic Angiography and Angioplasty," J. Am. Coll. Card., vol. 22, 1993, p. 1273.|
|36||Scharader, R., "Collagen Appl.," Catheterization & Cardiovascular Diagnosis, 1992, p. 298.|
|37||Schievink, "Intracanial Aneurysms," The New England Journal of Medicine; Review Articles, Jan. 2, 1997.|
|38||Silber, S., "Rapid Hemostasis of Arterial Puncture Sites with Collagen in Patients Undergoing Diagnostic Interventional Cardiac Catherterization," Clinical Cardiology, vol. 20, 1997, p. 981.|
|39||Smith, T., "Percutaneous Transhepatic Liver Biopsy with Tract Embolization," Radiology, vol. 198, 1996, p. 769.|
|40||Szikora, "Combined Use of Stents and Cells to Treat Experimental Wide-Necked Carotid Aneuryms: Preliminary Results," AJNR AM Newradiol, Jun. 1994, p. 1091.|
|41||Szikora, "Endovascular Treatment of Experimental Anuerysms with Liquid Polymers," vol. 38, No. 2, Feb. 1996.|
|42||Turjman, "Combined Stent Implantation & Endosacular Coil Placement for Treatment of Experimental Wide-Necked Aneurysms," AJNRAM J. Neuroradio, Jun. 1994, p. 1087.|
|43||Vogelzang, Robert L., "A Modified Cope Introducing Dilator to Allow Straight Guide Wire Introduction," American Roantigen Ray Society, Feb. 1986, p. 381.|
|44||Yoshimoto, "Cerebral Anuerysms Unrelated to Arterial Bifurcations," Acta Neurochir (Wien), 1996, pp. 138, 958.|
|45||Zins, M., "US-Guided Percutaneous Liver Biopsy with Plugging of the Needle Track," Radiology, vol. 187, 1992, p. 841..|
|U.S. Classification||264/42, 264/43, 264/52|
|International Classification||A61B6/00, A61B17/00, A61B10/02, A61B10/00, A61B17/03, A61K49/04, A61B17/08, A61B19/00, A61B8/00|
|Cooperative Classification||A61B10/0233, A61B2017/00654, A61B2017/00637, A61B17/0057, A61B8/481, A61B19/54, A61B6/03, A61M31/005, A61B2019/5433, A61B6/485, A61B2017/00004, A61B6/481|
|29 Oct 2004||AS||Assignment|
Owner name: SUB-Q, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ASHBY, MARK;SING, EDUARDO CHI;REEL/FRAME:015950/0682
Effective date: 19990617
|26 Oct 2010||CC||Certificate of correction|
|7 Mar 2013||FPAY||Fee payment|
Year of fee payment: 4